Fifteen Years of Controlled Production and Consistency of Quality Attributes for a Glycosylated Monoclonal Antibody Therapy

Time

Wed, Jun 17 9:00AM
W 41

Title

Fifteen Years of Controlled Production and Consistency of Quality Attributes for a Glycosylated Monoclonal Antibody Therapy

Abstract Summary

Charge isoforms containing 0/1/2 C-terminal lysines and other acidic species, oligosaccharides on a conserved N-linked glycosylation site, and TNFa binding were assessed. A meta-analysis of clinical efficacy data over time facilitated comparison across and within studies.

Poster Presenter

Amy Varga
PhD,
Director, Biologics CMC Program Management,
AbbVie Inc
United States